MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, PTCA, CUTTING/SCORING

Model Number	2200-2515
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's dob, age at time of event, gender, or weight are unknown.This information was not available from the facility.During withdrawal, the angiosculpt device separated in two pieces.Recurrence of the malfunction could result in a prolonged procedure.No piece of the angiosculpt device was retained in the patient.Patient information regarding medical history is unknown.This information was not available from the facility.Foreign- (b)(6).The angiosculpt device was returned in two pieces.The device separated at the proximal shaft approximately 19 cm distal to the strain relief.Based on the complaint details, the angiosculpt device got stuck on the lesion.It is likely that some degree of force was applied by the user, resulting in the shaft separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.
Event or Problem Description
The angiosculpt device was used to treat the proximal lad, but was unable to advance distally to the lesion.During withdrawal, resistance was noted and the device was unable to be removed from the lesion.As a result, the device snapped in two pieces, but was able to be removed from the patient, leaving the guide wire in place.The procedure was completed with a competitor balloon.No patient injury reported.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Common Device Name: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• MDR Report Key: 9528624
• Report Number: 3005462046-2019-00017
• Device Sequence Number: 3175108
• Product Code: NWX
• UDI-Device Identifier: 00813132021184
• UDI-Public: 00813132021184
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• PMA/510(K) Number: P050018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2020
• Device Model Number: 2200-2515
• Device Catalogue Number: 2200-2515
• Device Lot Number: G17050056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2019
• Initial Report FDA Received Date: 12/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005